Trial Outcomes & Findings for Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS) (NCT NCT03126760)

Last Updated: 2021-07-12

Results Overview

The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

Baseline, Day 42

Results posted on

2021-07-12

Participant Flow

The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic.

Approximately 66 participants were planned at 25 sites; while only 35 were randomized using 31 sites, because of recruitment difficulties and the impact of the COVID-19 pandemic.

Participant milestones

Participant milestones
Measure	Acthar Gel Participants receive Acthar Gel under the skin once a day for 14 consecutive days	Placebo Participants receive Placebo under the skin once a day for 14 consecutive days
Overall Study STARTED	18	17
Overall Study Modified Intent to Treat (mITT)	18	17
Overall Study Completed Treatment	17	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acthar Gel n=18 Participants Participants receive Acthar Gel under the skin once a day for 14 consecutive days	Placebo n=17 Participants Participants receive Placebo under the skin once a day for 14 consecutive days	Total n=35 Participants Total of all reporting groups
Age, Continuous	40 years n=93 Participants	43 years n=4 Participants	40 years n=27 Participants
Age, Customized Adults 21-64 · ≤35	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Age, Customized Adults 21-64 · 36-45	10 Participants n=93 Participants	6 Participants n=4 Participants	16 Participants n=27 Participants
Age, Customized Adults 21-64 · 46-55	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Age, Customized Adults 21-64 · 56-64	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Female	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants	15 Participants n=4 Participants	30 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	18 participants n=93 Participants	17 participants n=4 Participants	35 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Day 42

Population: modified Intent to Treat (mITT)

Outcome measures

Outcome measures
Measure	Acthar Gel n=18 Participants Participants receive Acthar Gel under the skin once a day for 14 consecutive days	Placebo n=17 Participants Participants receive Placebo under the skin once a day for 14 consecutive days
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 Baseline	3.86 score on a scale Standard Deviation 1.122	3.85 score on a scale Standard Deviation 1.169
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 Day 42	2.92 score on a scale Standard Deviation 0.974	3.62 score on a scale Standard Deviation 1.485

Adverse Events

Acthar Gel

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Information Call Center

Mallinckrodt

Phone: 800-844-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Acthar Gel n=18 participants at risk Participants receive Acthar Gel under the skin once a day for 14 consecutive days	Placebo n=17 participants at risk Participants receive Placebo under the skin once a day for 14 consecutive days
Eye disorders Vision blurred	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Endocrine disorders Goitre	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Eye disorders Corneal degeneration	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Feeling jittery	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Generalised oedema	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site bruising	16.7% 3/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	23.5% 4/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site discomfort	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site erythema	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	11.8% 2/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site haemorrhage	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site inflammation	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site pain	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Injection site reaction	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Oedema peripheral	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Pain	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
General disorders Peripheral swelling	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Herpes zoster	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Nasopharyngitis	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Oral candidiasis	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Pharyngitis	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Tooth abscess	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Infections and infestations Urinary tract infection	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Injury, poisoning and procedural complications Contusion	11.1% 2/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Injury, poisoning and procedural complications Fall	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations Alanine aminotransferase increased	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations Heart rate increased	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations Lymphocyte count decreased	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations Neutrophil count decreased	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations Protein total decreased	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Investigations White blood cell count decreased	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Metabolism and nutrition disorders Fluid retention	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	11.8% 2/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Musculoskeletal and connective tissue disorders Plica syndrome	0.00% 0/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	5.9% 1/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
Nervous system disorders Dysgeusia	5.6% 1/18 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.	0.00% 0/17 • 42 days Treatment emergent serious and non-serious adverse events are recorded. Treatment emergent is defined as adverse events that started or worsened in severity on or after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.